Atrial FibrillationNCT01407588
Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
A study testing Magnetic navigation and Ablation performed with manual navigation in people with Atrial Fibrillation, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Magnetic navigation and Ablation performed with manual navigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2011to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Undergoing ablation for atrial fibrillation at St. Olavs Hospital
- Implanted Reveal
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.
- Conditions
- Atrial Fibrillation
- Being tested
- Magnetic navigation, Ablation performed with manual navigation
- Keywords
- Atrial fibrillation, Ablation
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic navigationProcedure or surgery
Ablation with use of the magnetic navigation system
Ablation performed with manual navigationProcedure or surgery
Atrial fibrillation ablation performed with manual navigation
| Study group | Role | What they receive |
|---|---|---|
| Magnetic navigation | Experimental | Not described Receives: Procedure: Magnetic navigation |
| Manual navigation | Experimental | Not described Receives: Procedure: Ablation performed with manual navigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with recurrence of atrial fibrillation after ablation
If the patient have had recurrence or not of atrial fibrillation after ablation. An implanted arrhythmia loop recorder (Reveal XT) is used for monitoring. Recurrence is defined as an attack of atrial fibrillation of more than 2 minutes. It will also be specified if the patient is referred for a second ablation procedure.
Measured: 2 years
Secondary outcomes (11)
Procedure time
Duration of the ablation procedure
Measured: Day 1(after ablation procedure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Complications during and after the ablation procedure. Major: pericardial tamponade, permanent atrioventricular (AV) block, major bleeding, cerebral embolus, infection, heart failure, death. Minor: minor bleeding and temporary AV block.
Measured: Day 1(after ablation procedure)
Exposure of radiation to health personnel involved in the procedure
Total time with use of of radiation equipment. Radiation exposure of the operator.
Measured: Day 1(after ablation procedure)
Amount of analgetics and sedatives given during procedure
As a measure of pain and discomfort experienced by the patient during the procedure, the amount of medications are assessed
Measured: Day 1
Pain
Pain scores on the Visual Analog Scale
Measured: After ablation(day 1)
Numbers of and types of catheters used
As a measure of resources needed for the procedure, the catheters used are registered. Numbers of and type of catheters are registered and total cost calculated.
Measured: During ablation(Day1)
Time with active ablation
Total time that electrical current has been used during the ablation
Measured: During the procedure(Day 1)
Total time nurses are occupied with the ablation
As a measure of cost and resources needed for the procedure
Measured: During the ablation(day 1)
Myocardial damage
Measured by Troponin-t and CK-MBAs
Measured: After ablation(day 1)
Cardiac volumes and function
Measured by echocardiography
Measured: 1 year
Quality of life
Measured by SF-36 and atrial fibrillation symptoms and severity checklist
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startAug 2011
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital, SINTEF Health Research
- Responsible party
- Sponsor
- Investigators
- Jan Paal Loennechen, PhD, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407588
- Sponsor's protocol ID
- 2010/3345-2
- Status last verified
- Mar 2017
- First submitted
- 8 Jun 2011
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Compared to Magnetic Navigation in Ablation for Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01407588
- Acronym / sponsor ID
- 2010/3345-2
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, Ablation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital, SINTEF Health Research
- Study start
- Aug 2011 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare manual and magnetic navigation in ablation for atrial fibrillation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic navigation | Experimental | Procedure: Magnetic navigation |
| Manual navigation | Experimental | Procedure: Ablation performed with manual navigation |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Undergoing ablation for atrial fibrillation at St. Olavs Hospital
- Implanted Reveal
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic navigationAblation with use of the magnetic navigation system | Procedure or surgery | Magnetic navigation |
| Ablation performed with manual navigationAtrial fibrillation ablation performed with manual navigation | Procedure or surgery | Manual navigation |
Primary outcome
Number of participants with recurrence of atrial fibrillation after ablation
Time frame: 2 years
If the patient have had recurrence or not of atrial fibrillation after ablation. An implanted arrhythmia loop recorder (Reveal XT) is used for monitoring. Recurrence is defined as an attack of atrial fibrillation of more than 2 minutes. It will also be specified if the patient is referred for a second ablation procedure.
11 secondary outcomes
Procedure time
Time frame: Day 1(after ablation procedure)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: Day 1(after ablation procedure)
Exposure of radiation to health personnel involved in the procedure
Time frame: Day 1(after ablation procedure)
Amount of analgetics and sedatives given during procedure
Time frame: Day 1
Pain
Time frame: After ablation(day 1)
Numbers of and types of catheters used
Time frame: During ablation(Day1)
Time with active ablation
Time frame: During the procedure(Day 1)
Total time nurses are occupied with the ablation
Time frame: During the ablation(day 1)
Myocardial damage
Time frame: After ablation(day 1)
Cardiac volumes and function
Time frame: 1 year
Quality of life
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Individual participant dataSharing planned: No
Related trials for Atrial Fibrillation
Active, not recruiting
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jan Paal Loennechen, PhD study chair
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic navigation and Ablation performed with manual navigation in people with Atrial Fibrillation, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with recurrence of atrial fibrillation after ablation (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.